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Most Neurologists Plan to Prescribe Oral Multiple Sclerosis Drugs, but Will Proceed with Caution

In a study published this week by Majestic Research, almost 60% of neurologists expressed unaided concern about the side effects/safety of oral MS therapies in development, including NVS’s Gilenia and MRK/EMD Serono’s oral cladribine. Despite their concerns, the vast majority of neurologists expect to prescribe these drugs if they are approved, as the new oral MS therapies are expected to be highly efficacious and more convenient for patients than available injectable therapies. Data from the study suggests that new orals will steal share primarily from multiple sclerosis market leaders, including BIIB’s Avonex and TEVA’s Copaxone.

In the next article it lists some of the side effects linked to Gilenia in clinical trials.

I would really have to quiz any Neurologist who would recommend this oral drug over the existing inject able types, or better yet, diagnostic testing for CCSVI and possible angioplasty.

Claims have not been made that the oral drug is any safer, more effective, or has less side effects. The only plus that they have given is it’s “ease of administering”, which I can appreciate, as giving myself weekly injections was no picnic.

But it’s still a drug without a long history, so, even with a FDA Approval, those patients who decide to take the oral drug, are they not then patients in a non IRB approved, non sanctioned, mass distribution/prescription Drug Trial?

FDA Panel Votes to Approve Gilenia, First Oral MS DrugJune 10, 2010

- An FDA expert advisory panel today overwhelmingly recommended approval of Novartis's Gilenia, the first oral drug for multiple sclerosis (MS).Gilenia (generic name, fingolimod) would be used for the relapsing form of MS. The drug significantly reduces MS attacks. However, it has serious side effects, with possible heart, lung, liver, and eye toxicity and increased risk of infection. Patients must be closely monitored, the panel advised.Gilenia is the first drug in its class. In MS, white blood cells attack the myelin sheathes that protect nerve cells. Gilenia keeps white blood cells penned up in lymph nodes by taking away the chemical key they need to unlock the lymph-node door.Fewer white blood cells mean fewer MS attacks. But it also means less protection against infections and cancers. Novartis has already promised to set up a careful program for educating and monitoring patients taking the drug. Moreover, the company will continue long-term studies to look for side effects that may occur with longer term use.Gilenia was invented as a new way to prevent rejection in kidney transplant patients. But at the necessary dosage, the drug was far too toxic. The dose that would be used to treat MS is five times lower than the lowest dose tested in the transplant studies.Even at this dosage, Gilenia can have severe toxicity. The FDA panel recommended that Novartis be required to study whether even lower doses of the drug might be effective in MS.included:Elevated liver enzymes Macular edema (swelling of the central portion of the retina, causing distorted vision) High blood pressure Shortness of breath Bronchitis Diarrhea Bradycardia (slowing of the heartbeat, seen only upon first treatment. The FDA panel recommends that patients be required to receive their first dose under medical supervision). Two fatal herpes infections occurred in MS patients treated with Gilenia at 2.5 times the 0.5 mg dose for which Novartis is seeking approval.So far, no more cancers have been seen in MS patients taking Gilenia than in patients taking an inactive placebo.

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I take so many drugs ! Just 4 years ago I was on 0 drugs. Every drug that I take has a long list of possible side effects.

There is one huge side effect of all the injectibles for me : after 2 1/2 years of injecting Copaxone and absolutely NO HELP with my pain I decided this July to stop. It wasn't really a decision... It was more of an emotional breakdown. I just decided it would improve my QOL to not take Copaxone and it has. I just hated being in terrible pain and then having to inject an expensive drug that does nothing to help my pain but MAY retard MS progression. I know everybody tells me I should take my Copaxone but I had had more than I could handle.

So if there is an oral drug that my neuro likes and it is covered by my insurance then I will take it. Otherwise NO DMDs for me.

Most Neurologists Plan to Prescribe Oral Multiple Sclerosis Drugs, but Will Proceed with Caution

In a study published this week by Majestic Research, almost 60% of neurologists expressed unaided concern about the side effects/safety of oral MS therapies in development, including NVS’s Gilenia and MRK/EMD Serono’s oral cladribine. Despite their concerns, the vast majority of neurologists expect to prescribe these drugs if they are approved, as the new oral MS therapies are expected to be highly efficacious and more convenient for patients than available injectable therapies. Data from the study suggests that new orals will steal share primarily from multiple sclerosis market leaders, including BIIB’s Avonex and TEVA’s Copaxone.

In the next article it lists some of the side effects linked to Gilenia in clinical trials.

I would really have to quiz any Neurologist who would recommend this oral drug over the existing inject able types, or better yet, diagnostic testing for CCSVI and possible angioplasty.

Claims have not been made that the oral drug is any safer, more effective, or has less side effects. The only plus that they have given is it’s “ease of administering”, which I can appreciate, as giving myself weekly injections was no picnic.

But it’s still a drug without a long history, so, even with a FDA Approval, those patients who decide to take the oral drug, are they not then patients in a non IRB approved, non sanctioned, mass distribution/prescription Drug Trial?

FDA Panel Votes to Approve Gilenia, First Oral MS DrugJune 10, 2010

- An FDA expert advisory panel today overwhelmingly recommended approval of Novartis's Gilenia, the first oral drug for multiple sclerosis (MS).Gilenia (generic name, fingolimod) would be used for the relapsing form of MS. The drug significantly reduces MS attacks. However, it has serious side effects, with possible heart, lung, liver, and eye toxicity and increased risk of infection. Patients must be closely monitored, the panel advised.Gilenia is the first drug in its class. In MS, white blood cells attack the myelin sheathes that protect nerve cells. Gilenia keeps white blood cells penned up in lymph nodes by taking away the chemical key they need to unlock the lymph-node door.Fewer white blood cells mean fewer MS attacks. But it also means less protection against infections and cancers. Novartis has already promised to set up a careful program for educating and monitoring patients taking the drug. Moreover, the company will continue long-term studies to look for side effects that may occur with longer term use.Gilenia was invented as a new way to prevent rejection in kidney transplant patients. But at the necessary dosage, the drug was far too toxic. The dose that would be used to treat MS is five times lower than the lowest dose tested in the transplant studies.Even at this dosage, Gilenia can have severe toxicity. The FDA panel recommended that Novartis be required to study whether even lower doses of the drug might be effective in MS.included:Elevated liver enzymes Macular edema (swelling of the central portion of the retina, causing distorted vision) High blood pressure Shortness of breath Bronchitis Diarrhea Bradycardia (slowing of the heartbeat, seen only upon first treatment. The FDA panel recommends that patients be required to receive their first dose under medical supervision). Two fatal herpes infections occurred in MS patients treated with Gilenia at 2.5 times the 0.5 mg dose for which Novartis is seeking approval.So far, no more cancers have been seen in MS patients taking Gilenia than in patients taking an inactive placebo.

A couple of years ago everyone was excited about the possibility of an oral drug that would replace the injectables. Not anymore I guess. What scares me is not this article but the fact that people have convinced themselves that an unproven treatment is a better option than treatments that have been proven through stringent clinical trials.

I was diagnosed 10 years ago. Since DAY 1, I was promised by neuros that there would soon be AN ORAL DRUG on the market.
This informations was never offered to me because I objected to injecting myself, because I did not. I rather enjoyed the whole process, having been a phlebotomist during college.
But that was always the first knee jerk response from THE NEURO.
So, now if there is an oral administered MS drug, I am sure the neuros will Rx it.
Since the injectables don't do anything anyway, and they know it, what does it matter to them if they change the RX to oral, have a greater patient complaince, and have a Win/Win situation, as far as they are concerned?
and yes, I felt better when I stopped that damned Avonex.
Rose2
No more MS. I have been Liberated! I take 1 Baby aspirin/day. and taking all of those other drugs out of my body is a huge help.

Since I'm on the waiting list for Albany, I am curious in that are you feeling better? What are the changes? Incidentally, I was told by a nurse at the MS clinic here that the "injectable drugs weren't as effective as we originally first thought." Yet, of course, people are still being prescribed them.

ThornyRose,
I am better in every symptom that I had from MS.
If you name it, I had it. I had the 30 bottle of meds by my bed to get me thru the pain, spasms, fatigue, etc. etc everyday.
No more CogFog, fatigue, weakness, pain. No more pain.
Just got back from our Labor Day BBQ with large group of people, many of whom I have not seen in one year, since my liberation.
Shocked is the word I heard all day. 'shocked'
Many are friends of friends who had heard I was doing well, but had not seen me for a year.
I was able to give out good CCSVI contact info to those who need it for loved ones. I saw hope in their eyes. It is great to be able to convey that hope to those who knew me 'when'!
I know they hope that their loved ones results can be as dramatic as mine and I hope so too.
Since I call my previous condition Swamp Brain I think I may now rename myself the Creature from the Green Lagoon.
or something as appropriate. Rose2

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